PMA P980035S828

Device: Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advis
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S828
Product code: NVZ
Decision date: 2026-01-23
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: modification to the cleaning process of manufacturing components received at the Medtronic final device manufacturing site

Current openFDA PMA Record#

Device: Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advis
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S828
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2026-01-23
Decision code: OK30
Date received: 2026-01-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modification to the cleaning process of manufacturing components received at the Medtronic final device manufacturing site